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Eculizumab in patients with classic PNH: A cost effectivity study.


- candidate number10748
- NTR NumberNTR3215
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2011
- Secondary IDs80-82500-98-9008 ZonMw
- Public TitleEculizumab in patients with classic PNH: A cost effectivity study.
- Scientific TitleEculizumab in patients with classic PNH: A cost effectivity study.
- ACRONYM
- hypothesisEvaluation of eculizumab treatment in PNH patients at home compared to treatment at the center of excellence in the Netherlands.
- Healt Condition(s) or Problem(s) studiedSatisfaction, Cost-effectiveness , Quality of life, Home treatment
- Inclusion criteria1. PNH patients treated with eculizumab;
2. Aged >= 18 years;
3. Informed consent.
- Exclusion criteriaNo informed consent.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2011
- planned closingdate1-jan-2013
- Target number of participants25
- InterventionsA questionnaire is filled in by patients. No intervention will be given because the patients are already using eculizumab.
- Primary outcomeSatisfaction of patients (home care versus intramural administration) determined by a treatment satisfaction questionnaire.
- Secondary outcome1. Quality of life (EORTC and Facit Fatigue scale);
2. Resource utilisation;
3. Indirect costs (productivity losses);
4. Utility assessments (EQ-5D);
5. Clinical outcomes: safety and sustained reduction of hemolysis;
6. Quality control.
- Timepoints1. 6 months treatment in the expert center;
2. 6 months treatment at home;
3. Patients fill in questionnaire every 1,5 months.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M. Reen, van
- CONTACT for SCIENTIFIC QUERIESDr. P. Muus
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryParoxysmal Nocturnal Hemoglobinuria (PNH) is a rare acquired benign stem cell disorder characterized by hemolysis, anaemia, abdominal pain and thrombophilia. The sypmtoms interfere strongly with patient's social and working life. The newly registered orphan drug eculizumab has changed the lives of PNH patients significantly. Patients have less fatigue and a remarkably improved quality-of-life. Administration of eculizumab is per i.v. infusion once every week. In the Netherlands PNH patients travel to Nijmegen for each eculizumab infusion. In this study patients already on eculizumab treatment and new patients after at least 3 months of treatment at the out-patient clinics of the Radboud University Nijmegen Medical Center will be offered eculizumab treatment by specialized nurses at home. Cost effectiveness, expressed as cost and patient satisfaction will be compared per patient over 6 months of treatment in the expert center and 6 months at home.
- Main changes (audit trail)
- RECORD22-dec-2011 - 16-jan-2012


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